Yale Journal of Health Policy, Law, and Ethics

Current Issue: Volume 23, Issue 1

Artificial Womb Technology: Emerging Legal and Bioethical Debates in Ectogestation

Nina Roesner, Susanna McGrew, Chloe Connor, and Benjamin E. Berkman

After decades of research, clinical availability of partial ectogestation facilitated by artificial womb technology (AWT) now appears imminent. The AWT poised to enter clinical use is both practically and conceptually distinct from other reproductive technologies. Legal regimes governing pregnancy and childbearing draw on a variety of complex and at times contradictory frameworks, and introduction of AWT will require application of these already convoluted legal regimes to situations they were not designed for. Furthermore, AWT may change collective ideas about gestation and childbearing in ways that give rise to new kinds of laws and regulations governing pregnancy and pregnant people. Uncertainty surrounding reproductive policy in the wake of the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization means that the consequences of AWT are both less predictable and more likely to be influenced by policymakers and activists seeking to restrict reproductive rights. The purpose of this paper is first to situate AWT within existing legal frameworks governing gestation and reproduction and then, because those frameworks are insufficient to accommodate the novelty of AWT, to explore related bioethical debates likely to inform legal developments. In Part I, we describe the legally and ethically salient features of artificial womb technology and policy debates that may flow from them. In Part II we provide further background on the science and expected uses of AWT. In Part III, we identify different interests and interest holders implicated in these policy debates and assess how they relate to each other and to ectogestation. In Part IV, we examine existing law and legal principles that policymakers may draw on in response to novel questions raised by ectogestation. Finally, in Part V we explore gaps in the law where resolution of legal uncertainty implicates longstanding bioethical questions.

The Food Quality Protection Act: Empirical Evidence of a Thirty-Year Failure to Protect the Nation’s Children from Pesticide Residues and What to Do About It

Valerie J. Watnick and Sarah J. Beaumont

In 1996, amid a worldwide proliferation of pesticide use, Congress passed the Food Quality Protection Act in light of scientific reports that called attention to the dangers that pesticides pose to children. Experts hailed the FQPA as “one of the most significant environmental and public health bills passed in 20 years.” This paper assesses the Environmental Protection Agency’s track record in enforcing the FQPA to protect children and finds that the Act has fallen short of what Congress intended and what experts believed was possible. The paper lays out new empirical evidence to document the EPA’s record in child-related safety decisions. After examining the EPA’s three-decade track record, we suggest future actions to improve the Agency’s current approach to setting pesticide limits on foods. We also offer concrete suggestions for administrative actions to better protect children from pesticide exposures in food. This article intends to spur a critical shift in public and administrative policy and to serve as a clarion call to better align regulatory action with what Congress intended in passing the FQPA.

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Expanding Equity and Innovation in Pharmaceutical Law and Drug Development: Paying Clinical Trial Participants for their Data

Steve Calandrillo, Bernadette Tosti, Jefferson Smith, and Jamison Koeman

Bringing a drug to market is exceedingly expensive and exposes pharmaceutical manufacturers to significant legal risk. But when companies are successful, their profits make the PowerBall jackpot look like petty cash. Staggering rewards measure in the billions or millions for the firms, CEOs, pharmacies, drug benefit managers, data brokers, and many more actors in the pharmaceutical-to-patient pipeline. The only individuals who don’t get paid handsomely are the clinical trial participants, whose voluntary participation and data helped make those successes possible. It is long past time that we reform the legal and regulatory roadblocks to paying clinical trial participants in the United States for the fair value of their data—for it is precisely their information (and personal sacrifice) that makes so many others in our country wealthy beyond imagination.